SARS-CoV-2 OTC At Home Test

NCT05553964 | Terminated FDA Device

• 1 other identifier: 3EO-CoV2-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of this study is to evaluate the 3EO Health COVID-19 Test in individuals presenting at a medical facility. In eligible subjects, nasal samples will be collected for use with the 3EO Health COVID-19 Test, which will be compared to the Zymo® rRT-PCR test results obtained via samples specified by the manufacturer (e.g., AN \[anterior nares\] swab) to determine accuracy of the 3EO Health COVID-19 Test in detecting COVID-19 in participants.

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (1)

• Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.

  The primary endpoints of this study will be the correlation of the 3EO Health SARS-CoV-2 OTC At Home Test results from nasal samples to the comparator, standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.

  1-16 weeks

Study Arms (1)

Study Groups

EXPERIMENTAL

Positives: Symptomatic vs. Asymptomatic Negatives: Symptomatic vs. Asymptomatic Each broken down by age groups: 2-14 years old 15-24 years old 25-64 years old 65+ years old

Diagnostic Test: In Vitro

Interventions

In Vitro DIAGNOSTIC_TEST

In vitro diagnostic test for COVID-19 using anterior nasal swabs.

Study Groups

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals suspected of COVID-19 disease by a healthcare provider or individuals who have tested positive within the past 7 calendar days with a confirmed positive COVID-19 test
• Individuals able to self-administer the investigational test either upon themselves or upon their child (under sixteen (16) years of age) as a parent or guardian
• Individuals willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)

You may not qualify if:

• If symptomatic, individuals with self-declared symptoms greater than 7 days (plus/minus 1 day, if symptoms start not definite)
• Unable to provide consent or obtain consent from a LAR
• Unwilling or unable to collect all sample types
• Enrolled in a study to evaluate an investigational drug
• Eating/drinking/smoking 30 minutes prior to specimen collection
• Prisoner or under incarceration
• Have contraindications to the collection of nasal specimens from the nares/nostrils, such as but not limited to nasal ulcers or nasal surgery within 3 months prior to sample collection

Sponsors & Collaborators

• 3EO Health: lead

Study Sites (5)

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

I.V.A.M. Clinical & Investigational Center

Miami, Florida, 33144, United States

Location

Sunrise Research Institute

Sunrise, Florida, 33325, United States

Location

Vytalus Medical Atascocita

Humble, Texas, 77346, United States

Location

Vytalus Medical

Kingwood, Texas, 77339, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

In Vitro Meat

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jerika Acosta

  Medicept Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 26, 2022
• Study Start: October 7, 2022
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)